London, UK--(Marketwire - December 10, 2007) -
U.S. FDA ISSUES APPROVABLE LETTER
FOR REQUIP(R) XL(TM) EXTENDED RELEASE TABLETS
LONDON, UK, 10 December 2007-- SkyePharma PLC (LSE: SKP) today announces
that the United States Food and Drug Administration (FDA) has issued an
approvable letter for GlaxoSmithKline's (NYSE:
GSK) Requip® XL™
Extended Release tablets. An approvable letter is an official
notification from the FDA that contains conditions that must be satisfied
prior to obtaining final U.S. marketing approval.
Requip® XL™ is a once-daily oral dopamine agonist developed for the
treatment of the signs and symptoms of idiopathic Parkinson's disease.
The new Requip® XL™ formulation uses SkyePharma's patented
GEOMATRIX™ technology and is designed to provide a steady rate of
absorption in the body to help reduce daily blood plasma fluctuations.
GSK is committed to working with the FDA to address any questions they
have and evaluate the best way forward.
Requip® XL™ is approved in eight countries in Europe and a mutual
recognition procedure was successfully completed on 27 November 2007, in
17 additional European countries. This step should result in approval of
Requip® XL™ and launches in these countries from the first quarter
of 2008 onwards.
For further information please contact:
SkyePharma PLC Frank Condella +44 20 7491 1777
Ken Cunningham
Peter Grant
Financial Dynamics (UK Enquiries) David Yates +44 20 7831 3113
Deborah Scott
Trout Group (US Enquiries) Christine Labaree +1 617 583 1308
Seth Lewis
About SkyePharma PLC
Using its proprietary drug delivery technologies, SkyePharma develops new
formulations of known molecules to provide a clinical advantage and
life-cycle extension. The Company has eleven approved products in the
areas of oral, inhalation and topical delivery. The Group's products are
marketed throughout the world by leading pharmaceutical companies. For
more information, visit
www.skyepharma.com
About GlaxoSmithKline
Requip® XL™ was developed and is marketed by GlaxoSmithKline, one of
the world's leading research-based pharmaceutical and healthcare
companies. More information on GlaxoSmithKline is available at the
company's website at
www.gsk.com.
This information is provided by RNS
The company news service from the London Stock Exchange